MEDICATION GUIDE

Levetiracetam TabletsRx Only

Read this Medication Guide before you start taking levetiracetam and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about levetiracetam?

Like other antiepileptic drugs, levetiracetam may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying

attempts to commit suicide

new or worse depression

new or worse anxiety

feeling agitated or restless

panic attacks

trouble sleeping (insomnia)

new or worse irritability

acting aggressive, being angry, or violent

acting on dangerous impulses

an extreme increase in activity and talking (mania)

other unusual changes in behavior or mood

Do not stop levetiracetam without first talking to a healthcare provider.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

What is levetiracetam?

Levetiracetam is a prescription medicine taken by mouth that is used with other medicines to treat:

partial onset seizures in people 4 years of age and older with epilepsy

myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy

primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy.

It is not known if levetiracetam is safe or effective in children under 4 years of age.

Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your bottle and the appearance of your medicine with the description of levetiracetam provided below. Contact your pharmacist immediately if you believe a dispensing error may have occurred.

Levetiracetam tablets, 250 mg are blue coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘87’ on other side.

Levetiracetam tablets, 500 mg are yellow coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘88’ on other side.

Levetiracetam tablets, 750 mg are orange coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘90’ on other side.

Levetiracetam tablets, 1000 mg are white coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘91’ on other side.

What should I tell my healthcare provider before starting levetiracetam?

Before taking levetiracetam, tell your healthcare provider about all of your medical conditions, including if you:

have or have had depression, mood problems or suicidal thoughts or behavior

have kidney problems

are pregnant or planning to become pregnant. It is not known if levetiracetam will harm your unborn baby. You and your healthcare provider will have to decide if you should take levetiracetam while you are pregnant. If you become pregnant while taking levetiracetam, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of levetiracetam and other antiepileptic medicine during the pregnancy.

are breast feeding. Levetiracetam can pass into your milk and may harm your baby. You and your healthcare provider should discuss whether you should take levetiracetam or breast- feed; you should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your healthcare provider.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take levetiracetam?

Take levetiracetam exactly as prescribed.

Your healthcare provider will tell you how much levetiracetam to take and when to take it. Levetiracetam is usually taken twice a day. Take levetiracetam at the same times each day.

If you miss a dose of levetiracetam, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.

If you take too much levetiracetam, call your local Poison Control Center or go to the nearest emergency room right away.

What should I avoid while taking levetiracetam?

Do not drive, operate machinery or do other dangerous activities until you know how levetiracetam affects you. Levetiracetam may make you dizzy or sleepy.

Call your healthcare provider right away if you have any of these symptoms:

mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. A few people may get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior.

extreme sleepiness, tiredness, and weakness

problems with muscle coordination (problems walking and moving)

The most common side effects seen in people who take levetiracetam include:

sleepiness

weakness

dizziness

infection

The most common side effects seen in children who take levetiracetam include, in addition to those listed above:

accidental injury

irritability

hostility

These side effects can happen at any time but happen more often within the first 4 weeks of treatment except for infection.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of levetiracetam. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store levetiracetam?

Store levetiracetam at room temperature, 20°C to 25°C (68°F to 77°F) away from heat and light.

Keep levetiracetam and all medicines out of the reach of children.

General information about levetiracetam.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levetiracetam for a condition for which it was not prescribed. Do not give levetiracetam to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about levetiracetam. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about levetiracetam that is written for health professionals.